Multisite Study: Parental Training Using Video Modelling to Develop Social Skills in Children With Autism

Phase 4

Completed

• Conditions: Autism Spectrum Disorders
• Interventions: Behavioral: ABA parent training

• Registration Number: NCT02235467
• Lead Sponsor: Federal University of São Paulo

Brief Summary

This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis (ABA) parent training using video modeling to teach parents of children with Autism techniques to apply to their children in order to improve eye contact and joint attention behaviors.

Our hypothesis is that children with Autism whose parents will be trained by videomodeling will have better eye contact and joint attention behaviors compared to children with Autism whose parents will not be trained.

Detailed Description

Applied Behavior Analysis (ABA) is an intervention with proven efficacy in treating impairments on social functioning and daily-life activities of individuals with Autism Spectrum Disorder (ASD). In Brazil we have a limited number of qualified professionals and an increasing demand of families non-served in the public health system.

Our main objective is to standardize and test the efficacy of a model for parent training using video modeling for teaching eye contact and joint attention behaviors in children with ASD. These two behaviors are essential to develop adequate social interaction, the core impaired domain in ASD. It is a multisite study to be carried out at the Universidade Federal de São Paulo, Universidade de São Paulo and Universidade Presbiteriana Mackenzie. The sample will be composed of 70 children divided in control and intervention groups that will be randomly chosen. The intervention should be carried out in 21 weeks.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-09-05
• Study First Submitted QC: 2014-09-05
• Study First Posted: 2014-09-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Clinical Diagnosis of Autism Spectrum Disorders
• Diagnosis of Autism Spectrum Disorders by means of ADI
• IQ equal or lower than 70 by means of SON
• Main caregiver's level of education > primary education

Exclusion Criteria

• IQ lower than 50 by means of SON
• Child who is receiving ABA therapy at least 10 hours per week
• Main caregiver diagnosed with Autism Spectrum Disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABA parent training	ABA parent training	Applied Behavior Analysis parent training using videomodeling in 21 sessions

Primary Outcome Measures

Name	Time	Method
Acquisition from baseline of new behaviors at 8 weeks	baseline assessment to 8 weeks of therapy	acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
Acquisition from baseline of new behaviors at 16 weeks	baseline assessment to 16 weeks	acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
Acquisition from baseline of new behaviors at 21 weeks	baseline to 21 weeks	acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Zaritt Burden Interview at 21 weeks	baseline assessment to 21 weeks	The Zaritt Burden Interview measures the caregiver burden of taking care of the relative with psychiatric disorder
Change from baseline in Vineland Scale at 21 weeks	baseline assessment to 21 weeks	Adaptative behavior using Vineland Scale
Change from baseline in Eye-tracking at 21 weeks	baseline assessment to 21 weeks	Latency, duration, and sequence of visual fixations measured with eye-tracking
Change from baseline in SON-R 2½-7 at 21 weeks	baseline assessment to 21 weeks	Improve on SON-R 2½-7 that is an intelligence coefficient test developed for deaf people
Change from baseline in OERA at 21 weeks	baseline assessment to 21 weeks	OERA (Observação Estruturada para Rastreamento de Autismo) is a taped structured observation to screen Autism that was developed by Brazilian researchers.

Trial Locations

Locations (1)

Federal University of São Paulo Department of Psychiatry; 🇧🇷 São Paulo, Brazil